Potential Study Participants Research Articles

Leveraging the electronic health record patient portal to enhance clinical trial recruitment.

387 Background: The increasing prevalence of video/remote visits in the clinical setting has posed researchers with unique challenges related to clinical trial recruitment. Without the ability to speak to potential participants face to face, researchers rely on making phone calls which are frequently screened, declined, or never returned. Patients contacted in this way may never access the trials and care opportunities available to them. Electronic health record (EHR) patient portals, such as MyChart (Epic), allow individuals to access their medical records and communicate with their providers via instant messaging. This EHR tool may offer researchers a new method of participant recruitment to clinical trials. Methods: An electronic report, built around the Five- or Ten-Year Colonoscopy Trial’s (FORTE/NRG-CC005) eligibility criteria, was used to identify potential study participants. The local research team then generated an investigator endorsed, IRB-approved introductory script to send to patients via the MyChart instant messaging function. Once delivered, the message status was monitored to determine whether the patient had opened/read the introductory message. Patients who responded and expressed interest in trial participation were then sent additional information through MyChart and asked to schedule a time to speak to research staff over the phone. Results: In the two years that the FORTE trial was opened at our institution (October 2021 to August 2023), prior to implementing this MyChart practice, the research team attempted to contact 108 eligible patients via outreach phone calls. Of the 108, only 10 were reached by the study team and 0 consented to the trial. Between August 2023 and May 2024, 28 eligible patients were sent the MyChart script resulting in a response rate of 85.7% (24/28). Of the respondents, 20.8% (5/24) declined participation and did not want additional study information; 41.7% (10/24) requested more information but later declined participation, and 37.5% (9/24) expressed interest in trial participation. To date, of these 9 interested patients, 4 have enrolled to FORTE, and 5 are in the screening process. Conclusions: Preliminary observations suggest that recruiting patients to clinical trials through an electronic health record portal is an effective tool for enhancing enrollment. Further research is warranted to prospectively evaluate this recruitment strategy.

Co-producing research study recruitment strategies with and for children and young people for paediatric chronic pain studies.

Children and young people experiencing chronic pain are at greater risk of inequitable and poor-quality pain management, which has implications for future management of pain in adulthood. Most chronic pain research is conducted with adults who are more likely to be middle-class, white and monocultured. Inclusive and diverse recruitment practices in paediatric pain research can be an area in which we can address this imbalance of representation. The aim of this current work was to explore these practices and to co-produce recommendations regarding recruitment strategies for paediatric pain research. The research team worked with Your Rheum, a United Kingdom young person's advisory group (ages 11-24 years) and diagnosed with rheumatic condition(s), the opportunity to input into rheumatology research. At a virtual Your Rheum meeting, eight young people (female = 7, male = 1, age range 12-24) took part in group discussions, sharing their experiences of taking part in research and their decision process. Online tools, including Mentimeter and Miro, were used to aid conversations and share ideas. Most young people had experience of taking part in research as a study participant (n = 5). Recommendations synthesised included increased awareness of research in general. The young people discussed being open to hearing about research opportunities; they reflected that they are rarely exposed to these invitations or hear about current research. The clinic environment was highlighted as a "good and trustworthy" recruitment area - being approached by a member of the research team was considered ideal, even if it was someone they had not met previously. Many young people recalled little discussions of research at their clinical appointments. Deciding to participate in research included the following considerations: benefit/impact; connecting with others; research topic; which is then balanced against convenience, and reimbursement. The young people felt that taking part in research was empowering and helped them take ownership of their pain management. It is essential to understand the perspectives of potential study participants, to plan successful recruitment strategies. Ensuring we consider these factors when designing our studies and recruitment strategies is beneficial to all involved. Co-produced recruitment strategies would aid inclusive (and increased) research participation.

Screen Use Time and Its Association With Mental Health Issues in Young Adults in India: Protocol for a Cross-Sectional Study.

Screen use time has increased in the past decade owing to the increased availability and accessibility of digital devices and the internet. Several studies have shown an association between increased screen use time and mental health issues such as anxiety and depression. However, studies in the young adult population-a demographic with high screen use-and in low- and middle-income country settings are limited. This protocol describes a study that aims to measure self-reported screen use times and patterns in young adults (18-24 y) in India and assess if increased screen use time is associated with poorer mental well-being. This protocol describes a cross-sectional study of a pan-India, web-based convenience sample of young adults (18-24 y) with access to digital devices with a screen and a minimum of secondary school education. Participants will be recruited through people in the professional networks of the investigators, which includes pediatricians. The survey will also be distributed via the social media pages of our organization (X [X Corp], Instagram [Meta], Facebook [Meta], etc). Sociodemographic details will be collected through a questionnaire designed by the authors; screen use time and patterns will be assessed using an adaptation of the Screen Time Questionnaire to include data on different apps and websites used on digital devices; and mental health parameters will be gauged using the Warwick-Edinburgh Mental Well-Being Scale, Generalized Anxiety Disorder Scale, Perceived Stress Scale, and Patient Health Questionnaire. For statistical analysis, we will consider the following variables: (1) the primary independent variable is screen use time; (2) other independent variables include age, gender, residence: rural or urban, educational qualifications, employment status, stress associated with familial financial status, average sleep time, number of people living in a house or rooms in that house, BMI, substance use, and past psychiatric history; and (3) dependent variables include mental well-being, depression, anxiety, and perceived stress. To quantify the association between screen use time and mental health, we will perform a Bayesian multivariate multiple regression analysis that models the possibility of multiple alternative hypotheses while accounting for relevant sociodemographic covariables. The survey instrument has been designed, and feedback has been obtained from the domain experts and members of our organization whose profile is similar to the potential study participants. The final data received after this study has been conducted will be analyzed and shared. As of January 2023, we have not yet initiated the data collection. Based on the findings of this study, we will be able to establish a correlation between device- and use-specific screen use time and various mental health parameters. This will provide a direction to develop screen use time and mental health guidelines among young adults. PRR1-10.2196/39707.

Patient motivation as a predictor of digital health intervention effects: A meta-epidemiological study of cancer trials.

The objective of this meta-epidemiological study was to develop a rating that captures participants' motivation at the study level in digital health intervention (DHI) randomised controlled trials (RCTs). The rating was used to investigate whether participants' motivation is associated with the effect estimates in DHI RCTs for cancer patients. The development of the rating was based on a bottom-up approach involving the collection of information that captures participants' baseline motivation in empirical studies from the Smartphone-RCCT Database. We specified three indicators for rating: indicator 1 captures whether the study team actively selects or enhances the motivation of the potential study participants; indicator 2 captures the study participants' active engagement before the treatment allocation; and indicator 3 captures the potential bond and trust between the study participants and the person/institution referring to the study. The rating of each indicator and the overall rating varies between high motivation, moderate motivation, and low motivation. We applied the rating across 27 DHI RCTs with cancer patients. We performed meta-regression analysis to examine the effect of patient motivation on quality of life (QoL), psychological outcomes, and attrition. The intraclass correlation coefficient (ICC) indicated moderate to poor inter-rater reliability. The meta-regression showed that cancer patients' overall motivation before engaging in the intervention was associated with the treatment effect of QoL. Patient motivation was not found to be associated with psychological outcomes or attrition. Subgroup analyses revealed that the clinical effects of DHIs were more prevalent in the high-motivation subgroups, whereas the low-motivation subgroups were unlikely to show intervention benefits. The likelihood of dropouts from DHIs seems to be especially high among the low-bond (indicator 3) subgroup. We suggest using single indicators since they reflect specific content. Better reporting about baseline motivation is required to enable meaningful interpretations in not only primary studies but also in evidence syntheses.

1145 The Role of Emotional Intelligence in Surgical Leadership: A Qualitative Study

Abstract Aim Effective leadership is crucial in the NHS, enhancing patient safety and care quality. Surgical leaders play a vital role, addressing patient needs and managing teams (RCSEng, 2014). Emotional intelligence (EQ) is a key leadership skill, encompassing 12 competencies. However, EQ and leadership are often overlooked in medical training. This study investigates the significance of EQ in surgical leadership and aims to identify optimal methods for EQ development in surgery. Method The study employed semi-structured interviews (SSIs) with consultant and trainee surgeons, aiming to elucidate the influence of EQ on workplace behaviours in surgery. Ethical approval was obtained from the University of Nottingham Ethics Committee. Purposive sampling was used to select potential study participants with the aim of providing the most credible information to the study. Results Thematic analysis of transcribed interviews identified three overarching themes (Patients, Clinical Organisation, Surgeons) and related sub-themes. Results from 10 SSIs revealed that EQ positively affects job satisfaction, interpersonal relationships, teamwork, and mitigates burnout among surgeons. In the context of surgical leadership, EQ emerged as a catalyst for positive organisational culture change. Conclusions In conclusion, EQ is a crucial skill for surgical leaders, impacting various facets of their professional life. The study's findings contribute to the ongoing debate on the significance of EQ in surgery and advocate for evidence-based EQ training programmes in professional development. This research provides valuable insights for shaping effective leadership and training initiatives in the field of surgery.

Study protocol: A randomized, double-blind, placebo-controlled trial of isavuconazole prophylaxis for the prevention of covid-19-associated pulmonary aspergillosis

BackgroundDuring the early stages of the coronavirus disease 2019 (COVID-19) pandemic, those with severe COVID-19 infection were at risk for a number of opportunistic infections including COVID-19-associated pulmonary aspergillosis (CAPA). We initiated a randomized clinical trial to evaluate whether isavuconazole, a triazole antifungal, could prevent CAPA and improve survival in patients admitted to the ICU with severe COVID-19 infection. MethodsWe designed a phase III/IV randomized, double-blind, two-arm, placebo-controlled trial evaluating standard of care (SOC) plus isavuconazole versus SOC plus placebo and were to enroll participants admitted to the ICU with severe COVID-19 infection at three medical centers in California, United States. The projected sample size was 162 participants. ResultsDue to poor enrollment and the declining number of COVID-19 cases over time, the study was terminated after 7 participants were enrolled, all enrolled at one study site (UC San Diego Health). CAPA was suspected in two participants and they were started on open-label isavuconazole. One was withdrawn due to possible isavuconazole-related adverse side effects. ConclusionEnrollment was slower-than-expected due to multiple factors, including competing COVID-19-related studies and hesitancy from potential study participants or their families to join the study. Our experience highlights some of the difficulties in planning and running a clinical trial focused on fungal superinfections involving severely ill patients during the height of the COVID-19 pandemic. Lessons learned from this study will help in the design of proposed studies examining antifungal prophylaxis against aspergillosis following other severe respiratory viral infections.

104 Perceived Barriers to the Recruitment and Retention of Underrepresented Racial and Ethnic Groups (URGs) in Clinical Research

OBJECTIVES/GOALS: The inclusion of underrepresented racial and ethnic groups (URGs) in clinical research is critical for ethical and scientific reasons. This initiative aimed to assess the perspectives, barriers, needs, and recommendations encountered by research teams when enrolling and retaining URGs in clinical research. METHODS/STUDY POPULATION: An anonymous, web-based survey comprised of quantitative and qualitative questions was administered to individuals involved in clinical research at an academic medical center. The survey assessed three main domains: 1. Research teams' perceptions and experiences with enrolling URGs in clinical research, 2. Factors that discourage URGs from participating in clinical research, and 3. Research teams’ overall willingness to support URG enrollment. Demographics were also collected. The survey was reviewed by experts in clinical research, research ethics, and diversity, equity, inclusion, and accessibility (DEIA). The assessment was piloted among research professionals and edits were made accordingly prior to official dissemination. Data were analyzed using descriptive statistics. RESULTS/ANTICIPATED RESULTS: There was a total of 63 responses. A majority of respondents have more success enrolling patients whose primary language is the same as their own and that time arranging for an interpreter has negatively impacted enrollment efforts. Approximately half of the respondents believe that the race and/or ethnicity of the potential study participant influences enrollment success. Factors discouraging URGs from participating in clinical research include unavailability for follow-up visits due to transportation issues, distrust in doctors and/or researchers, fear of unknown side effects, and unavailability of medical interpreters. Respondents report that they are not discouraged from enrolling URGs and would utilize resources related to encouraging the inclusion of URGs DISCUSSION/SIGNIFICANCE: Language appears more influential than ethnicity or race when it comes to enrolling and retaining URGs. Additionally, it appears that enrolling is a bigger challenge than retaining. Major themes that emerge with respect to retaining enrolled participants include the inability to attend follow-up visits and the lack of incentives/compensation.

Development of a New Tool for Writing Research Key Information in Plain Language.

The complexity of research informed consent forms makes it hard for potential study participants to make informed consent decisions. In response, new rules for human research protection require informed consent forms to begin with a key information section that potential study participants can read and understand. This research study builds on exiting guidance on how to write research key information using plain language. The aim of this study was to develop a valid and reliable tool to evaluate and improve the readability, understandability, and actionability of the key information section on research informed consent forms. We developed an initial list of measures to include on the tool through literature review; established face and content validity of measures with expert input; conducted four rounds of reliability testing with four groups of reviewers; and established construct validity with potential research participants. We identified 87 candidate measures via literature review. After expert review, we included 23 items on the initial tool. Twenty-four raters conducted 4 rounds of reliability testing on 10 informed consent forms. After each round, we revised or eliminated items to improve agreement. In the final round of testing, 18 items demonstrated substantial inter-rater agreement per Fleiss' Kappa (average = .73) and Gwet's AC1 (average = .77). Intra-rater agreement was substantial per Cohen's Kappa (average = .74) and almost perfect per Gwet's AC1 (average = 0.84). Focus group feedback (N = 16) provided evidence suggesting key information was easy to read when rated as such by the Readability, Understandability and Actionability of Key Information (RUAKI) Indicator. The RUAKI Indicator is an 18-item tool with evidence of validity and reliability investigators can use to write the key information section on their informed consent forms that potential study participants can read, understand, and act on to make informed decisions. [HLRP: Health Literacy Research and Practice. 2024;8(1):e29-e37.].

Molluscum contagiosum survey – common approach and attitude towards treatment and research in Dutch general practice

BackgroundMolluscum contagiosum (MC) can cause significant burden in children. So far, pharmacological treatment has not been proven beneficial. More rigorous interventions have not been well studied. Current guidelines advise a “wait and see” policy. However, children and their parents frequently visit their GP requesting intervention. Therefore, the aim of this study was to gain insight into the approach to MC by GPs and parents’ expectations and to investigate willingness to participate in an interventional study.MethodsA survey study was carried out among GPs and parents using a questionnaire for each group inquiring about MC and potential study participation. Descriptive statistics were used to analyze results and logistical regression to investigate factors influencing participation.ResultsThe majority of GPs (88%) preferred an expectative approach; only 21% were willing to participate in a trial as proposed. GPs estimating ≥ 50% of parents would request treatment, were more likely to participate. Most responding parents did or would visit their GP requesting treatment. In contrast to GPs, 58% were willing to participate. Parents preferring cryotherapy or curettage were more likely to participate.ConclusionOur study demonstrated that the majority of GPs preferred a conservative approach, adhering to current guidelines. However, most parents preferred treatment to resolve MC and symptoms. Parents’ willingness to participate was much higher than GP’s, reflecting parents’ desire for treatment. These findings underscore the need for continued therapeutic research. Careful preparation and selection of GPs and patients will be essential to ensure the feasibility of such an endeavor.Trial registrationThis survey study was not part of a clinical trial.

Ethical considerations for biobanking and use of genomics data in Africa: a narrative review

BackgroundBiobanking and genomic research requires collection and storage of human tissue from study participants. From participants’ perspectives within the African context, this can be associated with fears and misgivings due to a myriad of factors including myths and mistrust of researchers. From the researchers angle ethical dilemmas may arise especially with consenting and sample reuse during storage. The aim of this paper was to explore these ethical considerations in the establishment and conduct of biobanking and genomic studies in Africa.MethodsWe conducted a narrative synthesis following a comprehensive search of nine (9) databases and grey literature. All primary research study designs were eligible for inclusion as well as both quantitative and qualitative evidence from peer reviewed journals, spanning a maximum of 20 years (2000–2020). It focused on research work conducted in Africa, even if data was stored or analysed outside the region.ResultsOf 2,663 title and abstracts screened, 94 full texts were retrieved and reviewed for eligibility. We included 12 studies (7 qualitative; 4 quantitative and one mixed methods).Ethical issues described in these papers related to community knowledge and understanding of biobanking and genomic research, regulation, and governance of same by research ethics committees, enrolment of participants, types of informed consents, data collection, storage, usage and sharing as well as material transfer, returning results and benefit sharing. ca. Biospecimen collection and storage is given in trust and participants expect confidentially of data and results generated. Most participants are comfortable with broad consent due to trust in researchers, though a few would like to be contacted for reconsenting in future studies, and this would depend on whether the new research is for good cause. Sharing data with external partners is welcome in some contexts but some research participants did not trust foreign researchers.ConclusionBiobanking and genomic studies are a real need in Africa. Linked to this are ethical considerations related to setting up and participation in biobanks as well as data storage, export, use and sharing. There is emerging or pre-existing consensus around the acceptability of broad consent as a suitable model of consent, the need for Africans to take the lead in international collaborative studies, with deliberate efforts to build capacity in local storage and analysis of samples and employ processes of sample collection and use that build trust of communities and potential study participants. Research ethics committees, researchers and communities need to work together to work together to adapt and use clearly defined ethical frameworks, guidelines, and policy documents to harmonize the establishment and running of biobanking and genomic research in Africa.

Paying a Heavy Price: Costs of Care for People With Severe Obesity in Nursing Homes.

The prevalence of resident obesity in nursing homes has increased dramatically from 22% to 28% between 2005 and 2015. To provide care for people with obesity, nursing homes have changed their admissions, staffing, and equipment, but underlying these changes are increased resources and financial costs of care. The purpose of this study is to describe nursing home organizational aspects of caring for older adults with obesity, with a focus on economic factors, from the perspective of nursing home staff and leadership. This qualitative study used descriptive approaches; data were collected through semistructured telephone interviews. Of 77 nursing home staff and leaders identified as potential study participants, 6 were ineligible, and 71 participated in the study through interviews conducted from 2019 to 2022. A total of 4 primary themes described the issues surrounding the cost of care for obesity in nursing homes: inefficient and risky use of staff time in a setting of persistent staff shortage, expensive and unique equipment needs, inadequate general reimbursement with an absence of obesity-specific reimbursement supplements, and competing short- and long-term management solutions. This qualitative study of nursing home staff and leadership underscores a need for improved approaches to funding obesity care within existing nursing payment models. The increasing prevalence of obesity and the burden of the costs of obesity care for nursing homes will escalate this need over the coming decade.

Diverse Research Teams and Underrepresented Groups in Clinical Studies

Several ophthalmic diseases disproportionately affect racial and ethnic minority patients, yet most clinical trials struggle to enroll cohorts that are demographically representative of disease burden; some barriers to recruitment include time and transportation, language and cultural differences, and fear and mistrust of research due to historical abuses. Incorporating diversity within the research team has been proposed as a method to increase trust and improve engagement among potential study participants. To examine how demographic factors of potential research participants and personnel may be associated with patient consent rates to participate in prospective ophthalmic clinical studies. This retrospective cohort study included patients from an urban, academic hospital who were approached for consent to participate in prospective ophthalmic clinical studies conducted between January 2015 and December 2021. Multivariable logistic regression assessing associations between patient and research personnel demographics and rates of affirmative consent to participate was used. In total, 1380 patients (mean [SD] age, 58.6 [14.9] years; 50.3% male) who were approached for consent to participate in 10 prospective ophthalmic clinical studies were included. Of prospective patients, 566 (43.5%) were Black; 327 (25.1%), Hispanic or Latino; 373 (28.6%), White; 36 (2.8%), other race and ethnicity; and 78 (5.8%) declined to answer. Black patients (odds ratio [OR], 0.32; 95% CI, 0.24-0.44; P < .001) and Hispanic or Latino patients (OR, 0.31; 95% CI, 0.20-0.47; P < .001) were less likely to consent compared with White patients. Patients with lower socioeconomic status were less likely to consent than patients with higher socioeconomic status (OR, 0.43; 95% CI, 0.33-0.53; P < .001). Concordance between patient and research staff race and ethnicity was associated with increased odds of affirmative consent (OR, 2.72; 95% CI, 1.99-3.73; P < .001). In this cohort study, patients from underrepresented racial and ethnic groups and those with lower socioeconomic status were less likely to participate in ophthalmic clinical studies. Concordance of race and ethnicity between patients and research staff was associated with improved participant enrollment. These findings underscore the importance of increasing diversity in clinical research teams to improve racial and ethnic representation in clinical studies.

Online qualitative research with vulnerable populations in the Philippines: Ethical and methodological challenges during COVID-19

Our article draws on two multi-sited studies to present the ethical and methodological challenges of conducting online qualitative research among vulnerable populations in the Philippines—specifically, among people who use drugs—during the COVID-19 pandemic. While the global scholarship has long articulated the difficulties inherent to pursuing research on such populations, we show how the specific milieu of the Philippines in the last three years has created exceptional, structural challenges to the conduct of said research. Besides the inevitable migration to online fieldwork brought about by the pandemic, researchers have had to contend with the continuing sociopolitical and existential threat to vulnerable populations posed by the government's drug war. Such a milieu, we argue, has further restricted access to potential study participants; redefined notions of intimacy and safety in conducting virtual data collection; and rendered people in vulnerable circumstances “more vulnerable” amid a climate of pandemic-induced precarity and aggravated distrust in the state—all of which have compelled researchers to undertake necessary innovations to uphold quality and equity in online research. We conclude by highlighting the need to maintain networks of trust with vulnerable communities, compensate research participants justly, and safeguard the independence of research institutions and people's trust in them.

Challenges in Accessing Mental Health Care during Pregnancy and Postpartum in Rural Montana.

Postpartum depression is a well-known maternal health care concern. For women using substances or experiencing underlying mental health conditions, incidence of postpartum depression is higher than that of the general population. The purpose of this study was to identify barriers and facilitators associated with seeking mental health care among women with substance use disorder or mental health concerns. Qualitative methods using interviews were conducted via the narrative inquiry approach. Women receiving care at a clinic in rural Montana and reporting substance use or mental health concerns were referred to the research team by the care manager. Participants were at least 18 years of age, English speaking, and pregnant or within 12 months postpartum at time of referral. Twenty-five women met inclusion criteria and were referred for potential study participation. Seven women were interviewed. Four themes on family history, stigmatization, lack of postpartum depression awareness, and isolation were identified. Our findings provide a better understanding of barriers and facilitators to seeking mental health care during pregnancy and postpartum among women living in rural areas with mental health concerns or perinatal substance use. An environment where opportunities for women to receive mental health care in a location that is free of stigma and judgment, while understanding the effects of familial trauma and limited or inconsistent social support, is essential to promote optimal outcomes.

Screening Out False Participants in Research Recruitment from Social Media Groups.

Social media-based groups offer a rich opportunity for nurse researchers to connect with potential study participants. However, as the authors discovered from recruitment of acute respiratory distress syndrome survivors in social media-based survivorship groups, there is a risk of enrollment of both false and duplicate participants. Nurse researchers should adopt best practices to screen out false participants and prevent duplicate participation. Lessons learned from recruitment in social media groups include avoiding the use of survey links, requiring video interviews or home visits for confirmation of identity, adoption of strategic screening questions, and avoidance of international groups (unless the aim is to recruit foreign nationals). Adoption of these practices can help to ensure that the data collected from group patrons are trustworthy. Nurses who read research and adopt findings into practice should critically examine if researchers implemented strategies to screen out false and duplicate participants to protect data integrity.

SA44 Digital Enrollment and Communication Acceptance for Decentralized Clinical Trial Participation

Study patient enrollment, initiation and communication has been made more efficient through the use of digital devices. However, there has been concern among sponsors that study participants are not comfortable with exchanging personal information digitally and a decentralized approach to engagement with a clinical study. This study sought to elucidate potential study participants’ preference toward a decentralized clinical trial (DCT) method of enrollment procedures and study staff communication

Understanding Recruitment Yield From Social Media Advertisements and Associated Costs of a Telehealth Randomized Controlled Trial: Descriptive Study.

Recruiting study participants for clinical research is a challenging yet essential task. Social media platforms, such as Facebook, offer the opportunity to recruit participants through paid advertisements. These ad campaigns may be a cost-effective approach to reaching and recruiting participants who meet specific study criteria. However, little is known about the extent to which clicks on social media advertisements translate to the actual consent and enrollment of participants who meet the study criteria. Understanding this is especially important for clinical trials conducted remotely, such as telehealth-based studies, which open the possibility to recruit over large geographical areas and are becoming more common for the treatment of chronic health conditions, such as osteoarthritis (OA). The aim of this study was to report on the conversion of clicks on a Facebook advertisement campaign to consent to enrollment in an ongoing telehealth physical therapy study for adults with knee OA, and the costs associated with recruitment. This was a secondary analysis using data collected over the first 5 months of an ongoing study of adults with knee OA. The Delaware Physical Exercise and Activity for Knee Osteoarthritis program compares a virtually delivered exercise program to a control group receiving web-based resources among adults with knee OA. Advertisement campaigns were configured on Facebook to reach an audience who could be potentially eligible. Clicking on the advertisement directed potential participants to a web-based screening form to answer 6 brief questions related to the study criteria. Next, a research team member called individuals who met the criteria from the screening form and verbally asked additional questions related to the study criteria. Once considered eligible, an electronic informed consent form (ICF) was sent. We described the number of potential study participants who made it through each of these steps and then calculated the cost per participant who signed the ICF. In sum, between July and November 2021, a total of 33,319 unique users saw at least one advertisement, 9879 clicks were made, 423 web-based screening forms were completed, 132 participants were successfully contacted, 70 were considered eligible, and 32 signed the ICF. Recruitment costed an average of US $51.94 per participant. While there was a low conversion from clicks to actual consent, 32% (32/100) of the total sample required for the study were expeditiously consented over 5 months with a per-subject cost well below traditional means of recruitment, which ranges from US $90 to US $1000 per participant. Clinicaltrails.gov NCT04980300; https://clinicaltrials.gov/ct2/show/NCT04980300.

Developing a Family Resource: Considerations for Family Member Research Participation.

When individuals participate in health care research, the choice often affects the entire family. Researchers are responsible for protecting participants and minimizing any burdens the research may place on them. Resources to educate potential study participants about these issues from a family perspective are lacking. A family-focused, evidence-based resource was created for individuals and families to prompt discussion prior to their consenting to enrollment in research. The resource includes key relevant questions to consider related to their study participation and was revised based on input from family nurse scientists and a hospital-based family advisory group. This resource raises awareness of the importance of employing a family lens when designing research and during the recruitment and enrollment of participants. Adopting a family lens in health care research will support the participant's ability to make an informed choice regarding participation and may ultimately enhance the experience of participants and their families and study outcomes.

Cutting-edge approach for Alzheimer’s disease detection in the early stages: an overview

Highlights Alzheimer’s disease (AD) is the leading cause of dementia. Selective memory impairment is a hallmark of AD. A novel blood test may identify the underlying toxin in AD. Amyloid-beta plaques outside of cells in the brain could not be harmful on their own. Alzheimer’s disease (AD) is the leading cause of dementia and a neurodegenerative ailment whose aetiology and pathophysiology are poorly understood. Selective memory impairment is a hallmark of AD and one of the first detectable symptoms in certain patients. Treatments exist to help with symptoms, but there is presently no cure, and the condition will worsen for all people eventually1. A novel blood test may identify the underlying toxin in AD, years before the onset of memory loss and cognitive decline. AD molecular pathology begins early on with the creation of toxic amyloid-peptide-beta (Aβ) oligomers2. Potentially elevated levels of phosphorylated tau181 (p-tau181) in the plasma are also associated with AD3. Impaired neural signalling, neuroinflammation, tau phosphorylation, and neurodegeneration are only some of the downstream impacts of these oligomers, and it is believed that they begin 10–20 years before the onset of symptoms4. However, new investigations have indicated that (Aβ) plaques are present in the brains of only about a third of Alzheimer’s patients, and that they are occasionally present in the brains of persons who exhibit no cognitive problems5. The Aβ plaques outside of cells in the brain could not be harmful on their own, but might be the result of other, more elusive toxins. The intricacies are still being worked out, but the concept has inspired scientists at the University of Washington to develop a very precise soluble oligomer binding assay (SOBA)6. Initially, 310 people’s blood plasma was used to test SOBA. The cognitive health of the subjects ranged from moderate impairment to full-blown AD. Blood plasma measurements of toxic Aβ oligomers were used by SOBA to identify all 53 people with Alzheimer’s, a diagnosis confirmed by autopsy. Also, 11 people in the control group had oligomers in their plasma tested by SOBA7. In retrospect, we know that 10 of the individuals had moderate cognitive impairment or Alzheimer’s. SOBA has the potential to be modified in the future to detect early signs of Parkinson’s disease, type II diabetes, and Lewy body dementia, all of which have been linked to protein misfolding. There have been several attempts to detect AD biomarkers, with mixed results. A blood screening that includes identifies A precursors indicated Alzheimer’s up to 30 years before the cognitive abnormalities ever started to manifest. Other researchers looked at the feasibility of using a novel blood testing tool called Simoa to assess tau concentrations and forecast the onset of AD8. More than 400 people’s blood was sampled by the team. They determined the quantity of p-tau181, a variant of tau associated with AD, in plasma (the blood’s liquid component). P-tau181 in plasma was shown to be different between healthy subjects and those with Alzheimer’s pathology verified in autopsy. Additionally, the test may be able to distinguish between Alzheimer’s pathology and that of a group of uncommon neurodegenerative disorders known as frontotemporal lobar degeneration. Results from the spinal fluid p-tau181 test and the positron emission tomography brain scan for Aβ protein were similar to those from the plasma p-tau181 test, both of which are considered to be reliable biomarkers for AD8,9. Now commonly used in clinical practice are blood tests screening for genes associated with AD. However, these tests are not very good at predicting who will get Alzheimer’s. With the use of a blood test, we could quickly screen a broader and more diversified pool of potential study participants. Improvements in early diagnosis of AD are a consequence of promising research such as SOBA and Simoa. Ethical approval Not applicable. Sources of funding No funding was received. Author contribution R.A.: conceptualization, data curation, writing – original draft preparation, and writing – reviewing and editing. B.K.D. and F.A.: data curation, writing – original draft preparation, and writing – reviewing and editing. T.B.E.: writing – reviewing and editing, visualization, and supervision. Conflicts of interest disclosure The authors declare that they have no conflicts of interest. Research registration unique identifying number (UIN) None. Guarantor T.B. Emran, PhD, Associate Professor, Department of Pharmacy, BGC Trust University Bangladesh, Chittagong 4381, Bangladesh. Tel: +880 303 356 193, fax: +880 312 550 224. https://orcid.org/0000-0003-3188-2272. Data availability The data in this correspondence article is not sensitive in nature and is accessible in the public domain. The data is, therefore, available and not of a confidential nature. Provenance and peer review Not commissioned, internally peer-reviewed.

Priorities to Promote Participant Engagement in the Participant Engagement and Cancer Genome Sequencing (PE-CGS) Network.

Engaging diverse populations in cancer genomics research is of critical importance and is a fundamental goal of the NCI Participant Engagement and Cancer Genome Sequencing (PE-CGS) Network. Established as part of the Cancer Moonshot, PE-CGS is a consortium of stakeholders including clinicians, scientists, genetic counselors, and representatives of potential study participants and their communities. Participant engagement is an ongoing, bidirectional, and mutually beneficial interaction between study participants and researchers. PE-CGS sought to set priorities in participant engagement for conducting the network's research. PE-CGS deliberatively engaged its stakeholders in the following four-phase process to set the network's research priorities in participant engagement: (i) a brainstorming exercise to elicit potential priorities; (ii) a 2-day virtual meeting to discuss priorities; (iii) recommendations from the PE-CGS External Advisory Panel to refine priorities; and (iv) a virtual meeting to set priorities. Nearly 150 PE-CGS stakeholders engaged in the process. Five priorities were set: (i) tailor education and communication materials for participants throughout the research process; (ii) identify measures of participant engagement; (iii) identify optimal participant engagement strategies; (iv) understand cancer disparities in the context of cancer genomics research; and (v) personalize the return of genomics findings to participants. PE-CGS is pursuing these priorities to meaningfully engage diverse and underrepresented patients with cancer and posttreatment cancer survivors as participants in cancer genomics research and, subsequently, generate new discoveries. Data from PE-CGS will be shared with the broader scientific community in a manner consistent with participant informed consent and community agreement.